AbbVie Inc (NYSE:ABBV) a research and development based international biopharmaceutical firm in cooperation with Neurocrine Biosciences, Inc. (NASDAQ:NBIX), reported detailed data from two replicate Phase III extension trials assessing the long-term safety and efficacy of elagolix, an investigational, orally administered GnRH antagonist, being assessed for the management of endometriosis with related pain.

In the extension trials, elagolix showed sustained decline in average monthly non-menstrual pelvic pain and menstrual pelvic pain in females through the 1-year treatment period. The tolerability and safety of elagolix was consistent with the projected effects of lowered estradiol levels and no new safety issues were identified with elagolix application for the 12-month treatment period. This data, and other additional abstracts, were showcased at the ASRM in San Antonio.

The details

Eric Surrey, M.D., expressed that endometriosis is a painful and chronic disease. The data showcased are positive for patients and are steady with previous data that showcase elagolix has the prospect to be a vital non-surgical treatment alternative for women with the most prevalent indications of endometriosis.

The goal of the extension trials was to assess the long-term efficacy and safety of elagolix for the management of endometriosis with related pain. The efficacy objectives of the pivotal trials were the proportion of responders depending on the average monthly non-menstrual pelvic pain and menstrual pain scores, as known by the Daily Evaluation of Endometriosis Pain scale. The reductions in non-menstrual pelvic pain and dysmenorrhea following six months of elagolix therapy were maintained over another six months of treatment across both extension trials for both 150 mg QD and 200 mg BID doses.

Over 50% of women were responders for non-menstrual pelvic pain and dysmenorrhea at both doses. The responder rate for dyspareunia after one year was more with the 200 mg BID dose as compared to the 150 mg QD dose, which showcases a dose-dependent effect similar to the impact noted in pivotal trials.

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